Clinical trial · Interventional
Intravitreal MTX and ZR Regimen in Newly Diagnosed PVRL
Combined Intravitreal Methotrexate and ZR (Zanubrutinib& Rituximab) Regimen Followed by Zanubrutinib Maintenance in Newly-diagnosed Primary Vitreoretinal Lymphoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a prospective single-arm phase II study, and the purpose of this study is to evaluate the efficiency of ZR regimen (rituximab \& Zanubrutinib) combined with intravitreal methotrexate and followed by Zanubrutinib maintenance in newly-diagnosed primary intraocular lymphoma. Progression-free survival (PFS) of the cohort is the primary endpoint.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Primary Vitreoretinal Lymphoma | Primary Vitreoretinal Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Methotrexate | Drug | Methotrexate | ALIAS |
| Rituximab | Drug | Rituximab | ALIAS |
| Zanubrutinib | Drug | Zanubrutinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Zanubrutinib/rituximab & intravitreal MTX
- description
- Experimental arm will be treated with rituximab plus zanubrutinib (ZR) regimen for 6 cycles and followed by zanubrutinib maintenance for 2 years, meanwhile, intravitreal methotrexate will be given as protocol during the 1st year of treatment.
- interventionNames
- Drug: Methotrexate
- Drug: Rituximab
- Drug: Zanubrutinib
Primary outcomes (1)
- measure
- 2 years progression-free survival
- timeFrame
- from the date of treatment to the subject finished his 2 years follow-up phase or the disease relapsed or the death due to lymphoma
- description
- 2 years progression-free survival was calculated from the date of therapy until death from lymphoma or 2-year follow up without relapsing
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Newly-diagnosed primary vitreoretinal lymphoma * ECOG≤2 * creatinine clearance rate (CCR) ≥ 60ml/h, according to Cockcroft-Gault * Total bilirubin # 2 upper limits of normal, alanine aminotransferase#ALT# \< 3 upper limits of normal * Sign the Informed consent * Women of childbearing potential must understand that the study medication could have a potential teratogenic risk. They should undergo complete contraception during the study period. * Male subjects must agree to use condoms throughout study drug therapy. Exclusion Criteria: * primary central nervous system lymphoma involved eyes and brain * systemic B cell lymphoma involved eyes * Pre-existing uncontrolled active infection * Clinical evidence of grade 3 or 4 heart failure as defined by the New York Heart Association criteria * Pregnancy or active lactation * Co-existing tumors * HIV or HBV or HCV
References
Publications (0)
Data not yet available